CN113631126A

CN113631126A - Easy-to-shape arm external fixation brace

Info

Publication number: CN113631126A
Application number: CN201980091400.9A
Authority: CN
Inventors: 向谷兮; 欧阳志伟
Original assignee: Wuhan Xunshu Technology Co ltd
Current assignee: Wuhan Xunshu Technology Co ltd
Priority date: 2019-02-12
Filing date: 2019-02-12
Publication date: 2021-11-09
Also published as: US20220125616A1; WO2020163994A1

Abstract

An arm external fixation support (10) is characterized in that the thickness (H) of the edge of the mesh plate (12) is greater than the thickness (B) of the central part. Preferably, the formula by weight of the raw material of the mesh plate (12) is: PCL60-78%; EVA20-38%; inorganic filler 2-20%; the thickness of the edge of the large ventilation hole of the mesh plate (12) The thickness is less than the thickness at the midpoint between two adjacent large ventilation holes; a plurality of snap substrates (300) are pre-embedded at the adjacent lateral edges of the mesh plate (12); the two wings of the snap substrate (300) are provided with sides A hole (305) is provided with grooves (302, 303) with symmetrical structures on both sides of the middle part of the snap substrate (300), and a middle hole (304) is provided in the middle of the snap substrate (300), in the grooves (302, 303) A check surface (301) is provided around the middle hole (304) on both sides of the base plate of the mesh plate; the two sides of the thumb hole (15) of the mesh plate (12) are symmetrical cone surfaces. The arm external fixation brace has few ingredients, but it can simultaneously achieve the contradictory indicators such as anti-adhesion during the molding process, easy to take out from the mold, convenient clinical operation, and comfortable wearing.

Description

Easy-to-form arm external fixing support

Technical Field

The invention relates to an arm external fixation brace, in particular to an easily-formed arm external fixation brace, belonging to the technical field of fracture external fixation.

Background

In the prior art, the medical fixing brace which can be attached to the arm most closely is formed by 3D printing. However, it has significant disadvantages. The brace must be divided into at least 2 parts that can be assembled together, rather than a brace blank; after the brace is worn on the arm, the tightness of the brace cannot be adjusted, and a connecting device capable of adjusting the tightness is not provided; the support is a curved three-dimensional structure, and is not a plane blank which is convenient for packaging, transportation, storage and use; the brace is not re-stretchable in use, rather than being arbitrarily stretchable in clinical use; the brace is hard, and not plastically deformable at will after being soaked in hot water.

In the prior art, the medical fixing brace which is most convenient to package, transport, store and use is of a reticular plate structure, the thickness of the product is uniform, certain parts are fleshy in the clinical use process, and the flexibility of the close-contact arm is not exerted to the utmost extent.

In the prior art, the bottom surface of the fixing device of the connecting structure of the arm fixing brace is not filled and leveled, and the bottom hole of the left buckle device can cause the damage of local skin blood supply badness, skin ulceration and the like, which is neglected for a long time.

In the prior art, the thickness around the thumb hole of the arm fixing support is not changed, the design of thickness gradual change is avoided, the comfort is poor, if a thumb fixing sleeve is added, the wearing comfort is worse, and the damage such as local skin poor blood supply and skin ulceration is easily caused.

The formula disclosed in CN102430156A is: PCL 30-50%; 0-20% of EVA; 35-50% of inorganic filler (talcum powder, calcium carbonate and silicate); 1-5% of a coloring agent; 0.1 to 1.0 percent of cross-linking agent.

201710945969.X discloses a formula by weight: PCL 40-75%; 0% of EVA; 18-50% of filling material (PP, PC, grafted PP); 7-10% of auxiliary materials (talcum powder, calcium carbonate and silicate); 0.1 to 1.0 percent of cross-linking agent.

In the prior art, the arm fixing brace has the disadvantages of more raw material components, complex material preparation process, complex manufacturing process, more control parameters and higher production cost.

Disclosure of Invention

The invention aims to provide an arm external fixation brace which is integrally molded by injection and is formed in one step, does not need to be cut and adhered in the using process, and is simpler and quicker for a doctor to operate.

Another object of the present invention is to provide a composite material for injection molding, which is easy to be demolded during injection molding, is not sticky during processing, simplifies the process, greatly reduces the production cost, and greatly improves the comfort of patients with a simpler formulation.

To this end, according to a first aspect of the present invention, there is provided an external arm fixation brace characterized in that the thickness of the edges of the mesh plate is greater than the thickness of the central portion.

Preferably, the thickness of the edge of the large ventilation hole of the reticular plate is smaller than the thickness of the middle point between two adjacent large ventilation holes.

Preferably, a plurality of buckle base plates are pre-embedded at the position, close to the transverse edge, of the mesh plate.

Preferably, the two wings of the buckle substrate are provided with side holes, two sides of the middle part of the buckle substrate are provided with grooves with symmetrical structures, the middle part of the buckle substrate is provided with a middle hole, and non-return surfaces are arranged around the middle holes on two sides of the substrate in the grooves.

Preferably, the recess is of non-circular configuration.

Preferably, the non-circular configuration is oblong, square, chordal, circular, or at least a configuration with a straight edge.

Preferably, the thickness of the edge of the thumb hole of the mesh plate thereof is larger as it is farther from the thumb hole.

Preferably, the two sides of the thumb hole of the mesh plate are conical surfaces with symmetrical structures.

According to a second aspect of the present invention there is provided a thumb-fixing brace accessory characterised in that it has a base and a thumb-holding cylinder, the base having a ramp and a base surface; the upper wall of the thumb-holding cartridge has at least one longitudinal slot; the side wall of the thumb holding cylinder is provided with at least one air vent; an annular connecting line with reduced thickness is arranged between the base and the thumb holding barrel.

Preferably, the thumb fixing brace is divided into a large size, a middle size and a small size, and the height is preferably 56mm, 64 mm and 72 mm; the length tolerance is +/-7 mm, the thickness tolerance is +/-2 mm, the base is in an oblong shape, the long diameter is 72mm, and the short diameter is 56 mm; the thickness of the base is preferably 1 mm.

According to a third aspect of the invention, a formula of the external arm fixing brace is provided, which is characterized in that PCL (polycaprolactone) is 60-78%; EVA (ethylene-vinyl acetate copolymer) 20-38%; 2-20% of inorganic filler.

Preferably, the inorganic filler may be talc, calcium carbonate, or silicate, etc.

According to a fourth aspect of the invention, a manufacturing process of an arm external fixation brace is provided, which is characterized in that a low-temperature, high-pressure, slow-speed and multi-point injection molding method is adopted.

Preferably, the sol temperature is set in the interval of 80-160 ℃; the injection pressure is 40-150 Mpa; the injection rate is in the interval of 2-25 g/s.

According to a fifth aspect of the present invention, there is provided a method of clinical use of an external arm fixation brace, wherein a thumb holding cylinder is inserted into a thumb hole of a mesh plate such that a slope of a base of the fixation brace fitting is in close contact with a slope of an edge of the thumb hole of the mesh plate, a gap between the base and the edge of the thumb hole is closed, and a base surface of the fixation brace fitting is flush with a base surface of the mesh plate.

According to the invention, the thickness of the plane of the reticular plate of the external arm fixing brace is not equal, but the thickness of the reticular plate in different areas is changed according to the anatomical structure of the human body, so that the wearing comfort and the fitting property are enhanced, but the function is unchanged.

According to the invention, the inner edge of the thumb hole of the mesh plate of the arm external fixation brace is provided with a circle of area with gradually changed thickness, and the inner edge of the thumb hole becomes thinner gradually towards the center of the thumb hole.

According to the invention, the mesh plate of the external arm fixing brace is additionally provided with the bottom inserting buckle of the connecting device, so that the strength of the connecting device is increased, and the bottom hole of the buckling device is sealed. The novel clamping device has the unexpected effect that the contact surface of the reticular plate and the skin is uniform and flat, and the damage of local skin poor blood supply, skin ulceration and the like caused by the bottom hole of the clamping device is avoided.

According to the invention, the reticular plate of the external arm fixing brace can be used clinically without dividing left and right arms, the operation is simple, the model number of the product can be reduced, the product batch can be increased, and the cost can be reduced. According to the invention, the mesh plate of the arm external fixation brace has the advantages of less raw material components, simple and convenient material preparation, less control parameters, simple manufacturing process and lower production cost.

Drawings

Fig. 1A is a schematic structural diagram of an external arm fixing brace in a middle body state according to an embodiment of the invention.

FIGS. 1B-1C are schematic partial thickness views of the extra-arm brace shown in FIG. 1A taken along lines S-S, X-X, Z-Z, Y-Y.

Fig. 2a-2b are schematic structural views of the embodiment shown in fig. 1A in a use state.

Fig. 3a-3e are schematic structural views of several embodiments of the locking connection device of the external arm fixing brace according to the present invention.

FIG. 4 is a schematic diagram of a thumb sleeve configuration according to one embodiment of the present invention.

Fig. 5 is a schematic structural view of a locking connection device of an external arm fixing brace according to an embodiment of the present invention.

Fig. 6 is a schematic view of an installation structure of the locking connection device shown in fig. 5.

FIG. 7A is a schematic view of the mounting arrangement of the anchoring end of the locking linkage shown in FIG. 6.

Fig. 7B is a schematic view of the mounting structure of the locking connection device endstop shown in fig. 6.

Fig. 8 is a schematic structural view of a locking connection device of an external arm fixing brace according to another embodiment of the present invention.

FIG. 9A is a schematic view of the mounting arrangement of the anchoring end of the locking linkage shown in FIG. 8.

Fig. 9B is a schematic view of the mounting structure of the locking connection device endstop shown in fig. 8.

Detailed Description

The invention provides a formula of a mesh plate raw material of an arm external fixation brace, which has few components, but can simultaneously realize the indexes of adhesion prevention in the molding process so as to be convenient to take out from a mold, convenient clinical operation (low-temperature thermoplastic property, certain ductility and adhesion prevention in clinical use), comfortable wearing and the like which are contradictory to each other.

According to one embodiment of the invention, the formulation by weight is: 60-78% of PCL (polycaprolactone); EVA (ethylene-vinyl acetate copolymer) 20-38%; 2-20% of inorganic filler (such as talcum powder, calcium carbonate, silicate, etc.).

Table one: and (3) formula test: ratio of respective ingredients (% by weight)

Performance testing

At 180 ℃, the test raw materials are put into an internal mixer according to the formula for melting modification, the modified raw materials are pressed into plates with the thickness of 5mm, and then samples with the size required by the test are cut. The following measurement method is adopted under the room temperature state (25 ℃ plus or minus 5, and the relative humidity is more than or equal to 50%):

method for measuring elongation:

the resulting film was prepared into a strip of 5mm x 10mm x 50mm (thickness x width x length), both ends of which were 10mm, respectively, and the strip was heated in water at 70 ℃ for 1 minute, then taken out, cooled at room temperature for 20 seconds, stretched to break with a force of 20N in the horizontal direction, and the stretch rate was calculated by measuring the stretch length.

The method for measuring the folding strength comprises the following steps:

the test pieces were prepared into strips of 5mm x 10mm x 100mm (thickness x width x length), the two ends were fixed 10mm apart to make the distance between the two ends 80mm, the test pieces were folded 130 ° upward and downward from the horizontal until cracks appeared, the number of folds was recorded, and the folding strength was calculated.

The uniformity detection method comprises the following steps:

the structure of the cut section of the strip-shaped plate is observed under a 1000-time microscope. The components must be uniformly distributed and no visible organic particles should be present.

Product matching viscosity:

making into strips of 5mm x 10mm x 50mm (thickness x width x length), heating in 70 deg.C water for 1 min, taking out, wiping to remove water, overlapping 50% of the area of 10mm x 50mm (width x length) plane for bonding, cooling, and applying 5N external force to prevent falling off. (the time from the removal of the product to the bonding of the sample is greater than 15 seconds and less than 20 seconds)

The method for measuring the product tensile resilience comprises the following steps:

making into strips of 5mm x 10mm x 50mm (thickness x width x length), fixing two ends 10mm respectively to make the distance between the two ends 30mm, stretching to 65mm (length) in horizontal direction, removing external force, allowing the product to retract naturally, measuring the retracted length of the sample, and calculating the resilience of the sample. (formula: S/65X 100%, S retraction length, S < 5% is none, S < 10% is slight, S < 20% is strong, S > 20% is strong)

Method for measuring injection molding conditions:

injecting the modified raw materials into a product according to the injection molding conditions of the invention, 1) placing the product under a magnifying glass of 10 times to observe whether the surface of the product is granular or not; 2) the surface of the product was visually inspected for shrinkage pits.

Injection molding conditions and methods:

because the characteristics of the modified raw materials are different from the injection molding conditions of general high polymer materials, the setting principle of the injection molding conditions of the modified raw materials is different from the injection molding conditions of the general high polymer materials, and the problems of injection molding and batch production of the formula are solved by adopting a low-temperature, high-pressure, slow-speed and multipoint injection molding method. The injection molding conditions are set according to the following data in a partitioned and segmented mode: 1) setting the sol temperature to be 80-160 ℃; 2) the injection pressure is 40-150 Mpa; 3) the injection rate is in the interval of 2-25 g/s.

Table two: test results

As can be seen from the test results of the detection schemes 1 to 14, when the content of PCL is less than or equal to 50%, the tensile rate of the product is less than 15%; the PP, PC and PCL are used for co-melting modification, the decomposition temperature of the PCL is 180-220 ℃, the melting temperature of the PP and PC is more than 200 ℃, and the decomposition temperature of the PCL is overlapped with the melting temperature of the PP and PC, so that the PP and PC are used for co-melting modification below the decomposition temperature of the PCL, and the product has unmelted PP and PC particles, so that the product performance is damaged; when the content of the inorganic filler is more than 30 percent, the product has poor tensile property and is easy to break. If only PCL and EVA are used for co-melting modification, shrinkage pits can appear in the injection molding process of the product, so that the appearance of the product is influenced; when the EVA content is more than or equal to 40%, the rebound rate of the product is increased, and the product shaping is influenced. Therefore, the PCL content is 60-78%, the EVA content is 20-38%, the inorganic filler is in the range of 2-20%, and the quality of the product after the co-melting modified material is injection molded is optimal.

Fig. 1A shows an external arm fixing brace 10 according to an embodiment of the present invention, in which a shape memory mesh plate 12 is formed in one step by a molding process and has a series of irregularly shaped large holes 11 distributed therein. The peripheral thickness of the mesh plate 12 is greater than the thickness of the middle part; the thickness of the periphery of each macro-aperture 12 is less than the thickness of the plate at the midpoint between adjacent macro-apertures 12.

FIG. 1B shows a partial thickness structure diagram of the top edge S-S, the left edge Z-Z, and the right edge Y-Y of the mesh plate 12, which has the common feature that the thickness H of the edge of the mesh plate is larger, the thickness B of the middle portion of the mesh plate is smaller, and the thickness G from the edge of the mesh plate to the middle portion of the mesh plate is gradually reduced.

Fig. 1C shows a partial thickness structure diagram of the lower edge X-X of the mesh plate 12, which is characterized in that the thickness H 'of the edge of the mesh plate is larger, the thickness B' of the middle portion of the mesh plate is smaller, the thickness G 'from the edge of the mesh plate to the middle portion of the mesh plate is gradually smaller, and more particularly, the thickness J' of the mesh plate is smaller toward the edge.

As shown in fig. 1A, 2a and 2b, the irregularly-shaped large hole 11 has a transition circular arc 13, the minimum transition radius is 0.5mm, and the minimum transition fillet is 10 degrees.

The span B is at least greater than the thickness t, preferably less than 50 times the thickness, more preferably less than 30 times the thickness.

The ratio of the maximum span L to the minimum span B is from 1:1 to 40:1, preferably from 1:1 to 30:1, more preferably from 1:1 to 20: 1.

The width b of the rib between two macro wells 11 is at least larger than the maximum thickness of the rib between two macro wells 11, preferably larger than 1.5 times the maximum thickness of the rib between two macro wells 11, more preferably larger than 2 times the maximum thickness of the rib between two macro wells 11.

The sum of the areas occupied by the macro-apertures 11 is 25-98%, preferably 27-80%, more preferably 29-60%, most preferably 30-55% of the area occupied by the shape memory mesh sheet 12.

The maximum thickness of the shape memory mesh sheet 12 is at least 3mm, preferably 4-6mm, more preferably 5 mm; for example, the thickness of the part 14 of the wrist bone convex part is thinner than other parts when the wrist bone convex part is used; a hole 15 with a specific shape is left at a part corresponding to the thumb, and the hole 15 with the specific shape can be peach-shaped, oblong, generally triangular and the like according to actual needs.

The adjustable external fixation brace 10 shown in FIG. 1A is used for rehabilitative fixation of a patient's arm. In other embodiments, the concepts of the present invention are equally applicable to the rehabilitation of fractures of limbs, chest, neck, waist, hands, feet, or other areas.

The two longitudinal sides of the adjustable external fixing brace 10 are provided with locking connecting devices 16, and the locking connecting devices 16 can be inserted, installed or bonded on the shape memory reticular lamina 12 or integrated with the shape memory reticular lamina 12; the thickness of the locking connection 16 may be approximately the same as the thickness at which the shape memory mesh panel 12 is installed.

In the embodiment shown in fig. 3a, the locking connection means 16 may be a non-return structure, and the locking connection means 16 installed at one side of the shape memory mesh plate 12 is provided with a non-return band 161, and the non-return band 161 has straight teeth 163; the locking connection means 16 installed at the other side of the shape memory mesh plate 12 is provided with a passing groove 162 of the check band 161 and a check rod 164, and the check rod 164 is not withdrawn when it is in contact with one of the straight teeth 163, so that the locking connection means 16 is locked; however, when check rod 164 is manually squeezed open, check band 161 can return to the free draw condition to facilitate release of locking connection 16.

In the embodiment shown in fig. 3b, the locking connection means 16 may be of a nylon tape structure, and the locking connection means 16 mounted on one side of the shape memory mesh panel 12 is provided with a nylon seat 161 having nylon wool 163; the locking connection means 16 mounted on the other side of the shape memory mesh panel 12 is provided with a nylon strap 162 on which a nylon loop 164 is provided. When the nylon velvet 163 and the nylon ring 164 are bonded together, the locking connecting device 16 is locked; however, when the nylon ring 164 is pulled apart manually, the locking connection 16 can be released.

In the embodiment shown in fig. 3c, the locking connection means 16 may be a toggle structure, and the locking connection means 16 installed at one side of the shape memory mesh plate 12 is provided with a toggle seat 161 having barbed teeth 163; the locking connection means 16 mounted on the other side of the shape memory mesh panel 12 is provided with a jaw 162 on which a hook 164 is provided. When the hook 164 is hooked on the tooth 163, the locking connection 16 is locked; however, when the trigger 162 is manually pulled open, the locking connection 16 is released.

In the embodiment shown in fig. 3d, the locking connection means 16 may be of a mortise and tenon type, and the locking connection means 16 installed at one side of the shape memory mesh panel 12 is provided with female connection portions 161 having a plurality of trapezoidal grooves 163 arranged in a row; the locking connection 16 mounted on the other side of the shape memory mesh panel 12 is provided with a male connection 162 with a trapezoidal head 164. When the trapezoidal head 164 is inserted into a trapezoidal groove 163, the locking connection device 16 is locked; however, when the ladder head 164 is pulled apart manually, the locking connection 16 can be released.

In the embodiment shown in fig. 3e, the locking connection means 16 may be a belt type fixing pin and hole structure, and the locking connection means 16 installed at one side of the shape memory mesh plate 12 is provided with a belt fixing end 161 having a belt fixing pin 163; the locking connection means 16 mounted on the other side of the shape memory mesh panel 12 is provided with a strap insertion end 162 provided with a series of insertion holes 164. When the fixing pin 163 is inserted into one of the insertion holes 164, the locking connection means 16 is locked; however, when the fixing pin 163 is manually removed from one of the insertion holes 164, the locking connection means 16 can be released.

According to the external arm fixing brace, when a doctor clinically uses the external arm fixing brace, firstly, a shape memory reticular plate which is made by adopting a high polymer material modification technology and is distributed with macropores is heated and softened at 70-80 ℃ (or heated and softened at 60-70 ℃); the softened shape memory reticular plate distributed with the macropores is surrounded at the position needing to be fixed of the patient within 15 minutes (preferably 12 minutes, more preferably 10 minutes) when the temperature is reduced to 65 ℃ (preferably lower than 60 ℃, more preferably lower than 50 ℃), and the shape memory reticular plate distributed with the macropores is attached to the position needing to be fixed of the patient through stretching extension and curved surface deformation; then combining the openings of the shape memory reticular plates distributed with the large holes.

FIG. 4 shows a thumb fastening brace fitting 20 having a base 2008 and a thumb retention cartridge 2009, the base 2008 having a ramp 2002 and a base 2003; the thumb hold cartridge 2009 has an upper wall 2004 and a lower wall 2005; the thumb hold cartridge 2009 has at least one vent hole 2007 in the side wall; the upper wall 2004 of the thumb holding cylinder 2009 has a groove 2006 for facilitating adjustment of the inner diameter according to the thickness of the thumb; between the base 2008 and the lower wall 2005, and between the base 2008 and the upper wall 2004, there is an annular connecting line 2001 which facilitates adjustment of the thumb hold cartridge 2009 into the most comfortable orientation for the patient.

In clinical use, the thumb holding cylinder 2009 is inserted into the thumb hole 15 of the mesh plate 12, such that the inclined surface 2002 of the base 2008 of the fixing brace fitting 20 is in close contact with the inclined surface 1202 of the edge of the thumb hole 15 of the mesh plate 12, the gap 1204 between the base 2008 and the edge of the thumb hole 15 is closed, and the base surface 2003 of the fixing brace fitting 20 is flush with the base surface 1201 of the mesh plate 12, thereby providing comfort for the patient to wear, promoting blood flow, and preventing partial ulceration of the thumb root.

The beveled surface 1202 on one side of the edge of the thumb hole 15 of the mesh plate 12 is symmetrical to the beveled surface 1203 on the other side so that the mesh plate 12 can be used with either the left or right arm and the thumb retention barrel 2009 can be used with either the left or right thumb. One can be multi-purpose, reduces the product model, increases the product batch, reduces product cost.

As shown in the embodiment of fig. 5, snap means 101, 102 are respectively installed at both sides of the mesh-plate assembly 100 adjacent to the lateral edges; the

fastening devices

101 and 102 are respectively provided with an anchoring end head part 103 and a stopping end head part 104 of a connecting belt 105 which can be rotatably installed relative to the reticular panel assembly 100; in clinical use, the mesh plate assembly 100 is shaped so that its inner surface I surrounds the wound of the patient, and on its outer surface O, the anchoring end 106 of the connecting strap 105 is secured within the head 103, while the stop end 107 is secured within the head 104, thereby closing the mesh plate assembly 100.

Fig. 6 is an enlarged partial schematic view of the snap-fit locating attachment means 101, 102. Fig. 7A-7B are exploded views of snap-fit locating and mounting

devices

101, 102.

5-6, 7A, 7B, a reticulated plate assembly 100 provided with a plurality of large vent holes is injection molded from a shape memory material, in accordance with one embodiment of the present invention; the front surface O, I and the back surface of each side of the reticular panel component 100 adjacent to the transverse edge are symmetrically provided with a plurality of mounting

holes

99, 98 for connecting the

buckle devices

101, 102 along the plate-shaped structure, or at least one surface is provided with a plurality of mounting

holes

99, 98 for connecting the buckles; at the mounting

pockets

99, 98, the thickness of the mesh plate assembly 100 is thinned; the mounting

cavities

99, 98 are provided with snap-fit features 111, 110.

The

buckle devices

101 and 102 are provided with a buckle fixing seat 111 and a buckle connecting column 119; the snap holders 111 are placed in the mounting pockets 98 provided at one side I of the mesh plate assembly 100, and the snap connection posts 119 are rotatably inserted into the snap holders 111 from the other side O of the mesh plate assembly 100 in a non-return manner.

The snap fastening seat 111 is provided with a check cylinder 114 capable of being elastically expanded in diameter, and the snap fastening column 119 is provided with a check head 112 having a check surface 117, after the check head 112 passes through the check cylinder 114, the check cylinder 114 elastically retracts in the radial direction, so that the end surface 118 of the check cylinder 114 contacts the check surface 114 of the check head 112, but the snap fastening column 119 can rotate freely within the check cylinder 114 within a range of 360 degrees.

Snap connection post 119 is further provided with

heads

103, 104 provided with

channels

120, 121 for retaining head end 122 of connecting band 105 and/or retaining end 123 of connecting band 105.

The channel for stopping the head end 122 of the connecting band 105 is a step square hole, and a stopping tongue 124 is arranged in the channel of the stopping end 123 of the connecting band 105, and preferably, a stopping tooth 125 is arranged on the stopping tongue 124.

The check cylinder 114 is arranged at the center of the buckle fixing seat 110, the buckle fixing seat 110 comprises a base plate, and the check cylinder 114 is arranged at the center of the base plate and is perpendicular to the base plate; preferably, the side wall of the non-return cylinder 114 is provided with at least one slit along its generatrix.

On both sides of the base plate in the longitudinal direction of the non-return cylinder 114, guide sleeves or guide rods 115 perpendicular to the base plate are symmetrically provided.

The check valve further comprises a snap cover plate 111, a central hole 126 matched with the outer peripheral surface of the check cylinder 114 is formed in the center of the snap cover plate 111, guide rods or guide sleeves 116 perpendicular to the snap cover plate 111 are symmetrically arranged on two sides of the central hole 126, and the guide rods or guide sleeves 116 are matched with the guide sleeves or guide rods 115.

The thickness of the base plate outside the guide sleeves or guide bars 115 in the longitudinal direction of the base plate is not greater than the thickness of the base plate between two guide sleeves or guide bars 115; the outer diameter of the end of the check cylinder 114 remote from the base plate is no less than the outer diameter of the end of the check cylinder 114 adjacent to the base plate; the non-return cylinder 114 is connected with the base plate through a supporting cylinder 113, and an included angle between the outer side wall of the non-return cylinder 114 and the inner side wall of the supporting cylinder 113 is an acute angle.

The sum of the height of the check cylinder 114 and the height of the check head 112 is less than the height of the support cylinder 113. The middle part of the filling and leveling plug 200 is inserted into the center hole of the check head 112 with a plurality of longitudinal slits, and the hooks of the check head 112 are pushed circumferentially, so that the check reliability is improved, and simultaneously, the filling and leveling plug 200 and the buckle fixing seat 110 are flush with the inner surface I of the reticular plate assembly 100.

As shown in fig. 8, 9A and 9B, according to another embodiment of the present invention, a mesh plate assembly 100 with a plurality of large ventilation holes is pre-embedded with a snap base plate 300 while being injection molded by a shape memory material. At the same time of injection molding the mesh plate 12, the side holes 305 of the two wings of the clip base plate 300 are filled with injection molding material, so that the clip base plate 300 and the mesh plate 12 are integrated. On both sides of the middle of the snap base 300, grooves 302,303 are provided with a symmetrical structure, so that if the mesh plate 12 is used for the left arm for mounting with the groove 302, then the mesh plate 12 is used for the right arm for mounting with the groove 303.

Preferably, the grooves 302,303 are of non-circular configuration, e.g. oblong, square, chordally cut circular, to prevent rotational displacement of the correspondingly shaped caulking member 200 within the

grooves

302, 303.

In the middle of the clip base 300, a central hole 304 is provided. Check surfaces 301 are provided on both sides of the substrate in the

grooves

302, 303.

The side wall of the snap connection column 119 is provided with at least one slit along its generatrix, and the end of the side wall is provided with a check head 112 with a check surface 117, after the check head 112 passes through the snap base 300, the check surface 117 of the check head 112 is clamped on the check surface 301.

The middle part 201 of the filling and plugging piece 200 is inserted into the central hole 129 of the check head 112 with a plurality of longitudinal slits, and the hooks of the check head 112 are pushed all around, so that the check reliability is improved, and simultaneously, the filling and plugging piece 200 is flush with the inner surface I of the reticular lamina 12.

According to the external arm fixing brace disclosed by the invention, the large-hole net design is convenient for directly viewing the change of the state of an illness, and the occurrence of complications after trauma is prevented; the ventilation is good, and the shower can be quickly dried; improves the skin hygiene of patients, prevents the occurrence of pruritus and dermatitis, and has light weight.

The external arm fixing brace disclosed by the invention is provided with the easily-detachable and adjustable locking and connecting device, the clamping tightness can be adjusted in the whole course of disease according to the swelling disease condition of a patient, the soft tissue compression is maintained, and the fixing effect is good.

According to the invention, the thermoplastic memory material is adopted, so that the stretching property is good, the deformation at any angle and in any direction can be generated, particularly, the net structure has better stretching property, and the application range of one specification (patients with different body types) is expanded. The specification number is reduced, the production cost is reduced, and the purchase quantity of hospitals is reduced.

According to the invention, the macroporous reticular plate manufactured by the one-time injection molding process has no punching process, no waste material and leftover material, no coating process, no need of additionally arranging a coating, no adhesion, high production efficiency and low manufacturing cost.

According to the invention, the net-shaped plate is made of a thermoplastic material which has good processability (injection-mouldable), has a certain ductility and is not adhered to the net-shaped plate, and is injection-moulded into the fixing brace for different parts (hands, limbs, neck, chest, waist or feet).

According to the invention, the mesh plate has a large-pore-shaped design, which facilitates ventilation; is composed of a single sheet or a plurality of sheets; locking connection device diversity; the pattern and thickness variation of the special part (such as the thickness of the ulna styloid process, the ankle bone and the like is less than or equal to that of other parts).

According to the invention, the fixing structure with different shapes or angles can be formed by stretching and deforming the affected part of the human fracture at will; the product joint does not need to be cut; the product can not be adhered; the product is composed of the same chemical components except for the locking connection device, and other substances do not need to be coated or impregnated on the surface; after being connected by the locking and connecting device, the irregular cylinder shape which is suitable for the appearance of the limb part of the human body can be formed; can fix all parts such as neck, chest, limbs, etc.; the fastening tightness of the brace is adjusted at will according to the swelling change of the fracture affected part; the disassembly is convenient, thus being beneficial to the treatment and nursing of the trauma of the affected part; the material does not absorb water and can be used for bathing.

The invention overcomes the prejudice of the traditional technology, does not honor the traditional process, is not limited by the traditional material selection, is greatly developed and innovated, selects new materials, new processes, new styles and new structures, and provides the rehabilitation brace which has lower manufacturing cost, simpler manufacturing process, more convenient use for doctors, safer and more comfortable wearing by patients and more suitable for fixing the fracture part of the human anatomy structure.

According to the invention, at the anchoring end and the locking end of the locking connection device, the connection column can be freely rotated, and in clinical use, no matter how the reticular lamina is stretched, the corresponding two anchoring ends and the locking end can be completely aligned through the adaptive steering adjustment, so that the connection of the external fixing brace is easy, and the adjustability is excellent.

According to the invention, the reticular plate used as the medical fixing brace does not need to be prepared for the left arm and leg and the right arm and leg respectively, so that the left arm, the right arm, the left leg and the right leg are universal, the batch of products can be improved, the cost can be further reduced, and the clinical use is facilitated.

The foregoing clearly discloses aspects of the present inventive concept and many modifications, substitutions, additions, modifications, variations, and the like may occur to those skilled in the art in light of the disclosed embodiments and fall within the scope of the present invention as defined in the accompanying claims.

Claims

The external arm fixing support features that the netted plate has edge thickness greater than that of the central part.
The extra-arm fixation brace of claim 1, wherein the web has edges of the large ventilation holes with a thickness less than the thickness at a midpoint between two adjacent large ventilation holes.
The external arm fixation brace of claim 1, wherein a plurality of snap-fit base plates are pre-embedded at the adjacent lateral edges of the mesh plate; preferably, the two wings of the buckle substrate are provided with side holes, two sides of the middle part of the buckle substrate are provided with grooves with symmetrical structures, the middle part of the buckle substrate is provided with a middle hole, and non-return surfaces are arranged around the middle holes on two sides of the substrate in the grooves; preferably, the groove is a non-circular configuration (e.g., oblong, square, chordal cut circular, or at least a configuration with a straight edge).
The external arm fixation brace of claim 1, wherein the web plate has a thumb hole edge with a thickness that increases further away from the thumb hole; preferably, the two sides of the thumb hole of the mesh plate are conical surfaces with symmetrical structures.
The extra-arm fixation brace of claim 1, wherein a thumb fixation brace fitting is provided having a base and a thumb retention cylinder, the base having a ramp surface and a base surface; the upper wall of the thumb-holding cartridge has at least one longitudinal slot; the side wall of the thumb holding cylinder is provided with at least one air vent; an annular connecting line with reduced thickness is arranged between the base and the thumb holding barrel.
The extra-arm fixation brace of claim 5, wherein the thumb fixation brace is sized large, medium, small, preferably 56, 64, 72mm in height; the length tolerance is +/-7 mm, the thickness tolerance is +/-2 mm, the base is in an oblong shape, the long diameter is 72mm, and the short diameter is 56 mm; the thickness of the base is preferably 1 mm.
The external arm fixation brace of claim 1, wherein the formula by weight is: 60-78% of PCL (polycaprolactone); EVA (ethylene-vinyl acetate copolymer) 20-38%; 2-20% of inorganic filler (the inorganic filler can be talcum powder, calcium carbonate or silicate, etc.).
The external arm fixation brace of claim 1, wherein a low temperature, high pressure, slow speed, multi-point injection molding process is used.
The external arm fixation brace of claim 8, wherein the sol temperature is set to be in the range of 80-160 ℃; the injection pressure is 40-150 Mpa; the injection rate is in the interval of 2-25 g/s.
The extra-arm fixation brace of claim 5, wherein in clinical use, the thumb retention cylinder is inserted into the thumb hole of the mesh plate such that the beveled surface of the base of the fixation brace fitting is in close contact with the beveled surface of the edge of the thumb hole of the mesh plate, the gap between the base and the edge of the thumb hole is closed, and the base surface of the fixation brace fitting is flush with the base surface of the mesh plate.